Ranitidine side effects: what 197,701 FDA adverse event reports show
Drug class
Not stated in label
Who reports
197,701 reports · 93% serious · 15,520 with death outcome · 52% female
Used for
Ranitidine Tablets are indicated in: Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
What it is
Ranitidine is a member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease. It has a role as a xenobiotic, a H2-receptor antagonist, an anti-ulcer drug, an environmental contaminant and a drug allergen.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,160 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 62 | 267.8 167.2–429.0ROR 267.9 · calibrated p 3e-10 ✓ | 73.8 EB05 59.6 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=62 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Haematopoietic neoplasm | 69 | 61.1 45.4–82.3ROR 61.2 · calibrated p 6e-6 ✓ | 38.5 EB05 31.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 0% (drug 52%) | not reported in cached trials |
| Colorectal cancer | 17,674 | 61.0 59.9–62.1ROR 66.9 · calibrated p 2e-6 ✓ | 38.8 EB05 38.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · 99% consumer | not reported in cached trials |
| Renal cancer | 16,278 | 53.9 52.9–54.9ROR 58.6 · calibrated p 5e-6 ✓ | 35.8 EB05 35.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · 98% consumer | not reported in cached trials |
| Oesophageal carcinoma | 9,648 | 50.0 48.9–51.3ROR 52.6 · calibrated p 1e-5 ✓ | 34.1 EB05 33.5 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 21.0 · ♀ 27% (drug 52%) · 98% consumer | not reported in cached trials |
| Hepatic cancer | 7,592 | 48.1 46.8–49.4ROR 50.0 · calibrated p 1e-5 ✓ | 33.2 EB05 32.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · 98% consumer | not reported in cached trials |
| Small intestine carcinoma | 701 | 47.7 43.7–52.2ROR 47.9 · calibrated p 2e-5 ✓ | 33.0 EB05 31.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=701 · 100% consumer | not reported in cached trials |
| Haemoglobin urine present | 62 | 45.9 34.0–61.9ROR 45.9 · calibrated p 3e-5 ✓ | 31.8 EB05 25.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=59 · ♀ 100% (drug 52%) | not reported in cached trials |
| Gastric cancer | 7,539 | 44.0 42.9–45.2ROR 45.7 · calibrated p 2e-5 ✓ | 31.2 EB05 30.6 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 · 98% consumer | NCT00401752: 2/107 (1.9%) on Ranitidine (serious AE) |
| Bladder cancer | 16,746 | 41.3 40.6–42.0ROR 45.0 · calibrated p 3e-5 ✓ | 29.8 EB05 29.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 26% (drug 52%) · 98% consumer | not reported in cached trials |
| Prostate cancer | 22,252 | 39.8 39.3–40.4ROR 44.8 · calibrated p 3e-5 ✓ | 29.1 EB05 28.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 1% (drug 52%) · 98% consumer | not reported in cached trials |
| Appendix cancer | 250 | 38.3 33.1–44.3ROR 38.3 · calibrated p 7e-5 ✓ | 28.2 EB05 25.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=250 · 100% consumer | not reported in cached trials |
| Breast cancer | 24,854 | 37.9 37.4–38.4ROR 43.2 · calibrated p 3e-5 ✓ | 28.0 EB05 27.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 98% (drug 52%) · 98% consumer | not reported in cached trials |
| Gastrointestinal carcinoma | 2,362 | 36.6 34.9–38.3ROR 37.0 · calibrated p 8e-5 ✓ | 27.3 EB05 26.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 97% consumer | not reported in cached trials |
| Gallbladder cancer | 373 | 35.7 31.7–40.2ROR 35.8 · calibrated p 1e-4 ✓ | 26.8 EB05 24.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=373 · 100% consumer | not reported in cached trials |
| Haematological malignancy | 705 | 34.9 32.1–38.0ROR 35.0 · calibrated p 1e-4 ✓ | 26.4 EB05 24.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=705 · 100% consumer | not reported in cached trials |
| Nasal cavity cancer | 222 | 33.4 28.7–38.9ROR 33.4 · calibrated p 2e-4 ✓ | 25.5 EB05 22.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=222 · ♀ 0% (drug 52%) · 100% consumer | not reported in cached trials |
| Pancreatic carcinoma | 6,840 | 32.5 31.6–33.4ROR 33.6 · calibrated p 1e-4 ✓ | 25.0 EB05 24.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · 99% consumer | not reported in cached trials |
| Testis cancer | 834 | 28.1 26.1–30.4ROR 28.2 · calibrated p 4e-4 ✓ | 22.3 EB05 21.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=834 · ♀ 0% (drug 52%) · 100% consumer | not reported in cached trials |
| Uterine cancer | 1,644 | 26.8 25.4–28.3ROR 27.0 · calibrated p 5e-4 ✓ | 21.5 EB05 20.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 95% (drug 52%) · 100% consumer | not reported in cached trials |
| Crystal urine present | 111 | 26.0 21.1–32.1ROR 26.0 · calibrated p 6e-4 ✓ | 20.9 EB05 17.9 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=107 · ♀ 82% (drug 52%) | not reported in cached trials |
| Brain neoplasm malignant | 888 | 25.9 24.1–27.9ROR 26.0 · calibrated p 6e-4 ✓ | 20.9 EB05 19.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=888 · 100% consumer | not reported in cached trials |
| Thyroid cancer | 2,299 | 24.7 23.6–25.8ROR 25.0 · calibrated p 7e-4 ✓ | 20.1 EB05 19.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 100% consumer | not reported in cached trials |
| Urinary sediment present | 117 | 23.5 19.2–28.7ROR 23.5 · calibrated p 0.001 ✓ | 19.3 EB05 16.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=113 · ♀ 100% (drug 52%) | not reported in cached trials |
| Cervix carcinoma | 652 | 20.9 19.2–22.8ROR 21.0 · calibrated p 0.002 ✓ | 17.6 EB05 16.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=652 · ♀ 100% (drug 52%) · 100% consumer | not reported in cached trials |
| Lung neoplasm malignant | 6,760 | 20.6 20.1–21.1ROR 21.3 · calibrated p 0.001 ✓ | 17.4 EB05 17.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · 97% consumer | not reported in cached trials |
| Urine leukocyte esterase positive | 115 | 20.4 16.7–24.9ROR 20.4 · calibrated p 0.002 ✓ | 17.2 EB05 14.7 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=112 · ♀ 100% (drug 52%) | not reported in cached trials |
| Tenosynovitis stenosans | 87 | 19.4 15.4–24.4ROR 19.4 · calibrated p 0.003 ✓ | 16.4 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Tongue neoplasm malignant stage unspecified | 256 | 18.8 16.5–21.5ROR 18.8 · calibrated p 0.003 ✓ | 16.1 EB05 14.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=256 · ♀ 30% (drug 52%) · 100% consumer | not reported in cached trials |
| Prostatic disorder | 837 | 18.8 17.4–20.2ROR 18.9 · calibrated p 0.003 ✓ | 16.0 EB05 15.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=678 · ♀ 0% (drug 52%) · 100% consumer | not reported in cached trials |
| Renal cancer stage i | 399 | 18.6 16.7–20.7ROR 18.7 · calibrated p 0.003 ✓ | 15.9 EB05 14.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=399 | not reported in cached trials |
| Throat cancer | 633 | 18.4 16.9–20.0ROR 18.5 · calibrated p 0.003 ✓ | 15.8 EB05 14.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=633 · 100% consumer | not reported in cached trials |
| Lung carcinoma cell type unspecified stage i | 140 | 17.9 14.9–21.4ROR 17.9 · calibrated p 0.004 ✓ | 15.3 EB05 13.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=140 · 100% consumer | not reported in cached trials |
| Lung carcinoma cell type unspecified stage ii | 66 | 17.4 13.4–22.5ROR 17.4 · calibrated p 0.004 ✓ | 14.9 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 0% (drug 52%) | not reported in cached trials |
| Renal cancer stage iii | 260 | 17.1 15.0–19.5ROR 17.1 · calibrated p 0.004 ✓ | 14.8 EB05 13.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=260 · 100% consumer | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 149 | 16.9 14.2–20.1ROR 16.9 · calibrated p 0.004 ✓ | 14.6 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=149 | not reported in cached trials |
| Red blood cells urine positive | 134 | 16.9 14.1–20.3ROR 16.9 · calibrated p 0.005 ✓ | 14.6 EB05 12.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=131 · ♀ 80% (drug 52%) | not reported in cached trials |
| Colorectal cancer stage i | 276 | 15.7 13.9–17.9ROR 15.8 · calibrated p 0.006 ✓ | 13.8 EB05 12.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=276 · 100% consumer | not reported in cached trials |
| Renal cancer stage ii | 233 | 15.2 13.3–17.5ROR 15.3 · calibrated p 0.007 ✓ | 13.4 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=233 · 100% consumer | not reported in cached trials |
| Ovarian cancer | 1,172 | 15.2 14.3–16.2ROR 15.3 · calibrated p 0.006 ✓ | 13.4 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 100% (drug 52%) · 100% consumer | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Malignancy | 71,365 | 24.624.5–24.8 | signal |
| Kidney injury | 6,218 | 1.51.4–1.5 | raised |
| Anaphylaxis / angioedema | 1,279 | 1.11.0–1.1 | raised |
| Hyponatraemia | 768 | 1.00.9–1.1 | no difference |
| Liver injury | 2,321 | 0.80.8–0.8 | lower than other drugs |
| Anaemia | 2,207 | 0.80.7–0.8 | lower than other drugs |
| Depression | 2,033 | 0.80.7–0.8 | lower than other drugs |
| Gi bleeding | 1,310 | 0.80.7–0.8 | lower than other drugs |
| Severe cutaneous reaction | 514 | 0.70.7–0.8 | lower than other drugs |
| Arrhythmia / qt | 1,331 | 0.70.7–0.8 | lower than other drugs |
| Neutropenia / agranulocytosis | 1,667 | 0.70.7–0.7 | lower than other drugs |
| Pancreatitis | 538 | 0.70.6–0.8 | lower than other drugs |
| Thrombocytopenia | 1,441 | 0.70.7–0.7 | lower than other drugs |
| Serious infection | 4,992 | 0.70.7–0.7 | lower than other drugs |
| Interstitial lung disease | 555 | 0.60.6–0.7 | lower than other drugs |
| Fall / fracture | 2,094 | 0.60.6–0.6 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ranitidine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT00401752 — Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Ga (N=397, PHASE3; 12 AE terms posted; arms: Esomeprazole; Ranitidine)
- NCT00838526 — Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Re (N=240, PHASE3; 19 AE terms posted; arms: RAN 150mg BID; RAB ER 50mg QD)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Breast cancer | 24,854 | 37.9 37.4–38.4ROR 43.2 · calibrated p 3e-5 ✓ | 28.0 EB05 27.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 98% (drug 52%) · 98% consumer | not reported in cached trials |
| Prostate cancer | 22,252 | 39.8 39.3–40.4ROR 44.8 · calibrated p 3e-5 ✓ | 29.1 EB05 28.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 1% (drug 52%) · 98% consumer | not reported in cached trials |
| Colorectal cancer | 17,674 | 61.0 59.9–62.1ROR 66.9 · calibrated p 2e-6 ✓ | 38.8 EB05 38.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · 99% consumer | not reported in cached trials |
| Bladder cancer | 16,746 | 41.3 40.6–42.0ROR 45.0 · calibrated p 3e-5 ✓ | 29.8 EB05 29.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 26% (drug 52%) · 98% consumer | not reported in cached trials |
| Renal cancer | 16,278 | 53.9 52.9–54.9ROR 58.6 · calibrated p 5e-6 ✓ | 35.8 EB05 35.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · 98% consumer | not reported in cached trials |
| Oesophageal carcinoma | 9,648 | 50.0 48.9–51.3ROR 52.6 · calibrated p 1e-5 ✓ | 34.1 EB05 33.5 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 21.0 · ♀ 27% (drug 52%) · 98% consumer | not reported in cached trials |
| Incorrect dose administered | 9,632 | 4.7 4.6–4.8ROR 4.9 · calibrated p 0.246 | 4.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 9.0 · serious PRR 10.4 | not reported in cached trials |
| Hepatic cancer | 7,592 | 48.1 46.8–49.4ROR 50.0 · calibrated p 1e-5 ✓ | 33.2 EB05 32.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · 98% consumer | not reported in cached trials |
| Gastric cancer | 7,539 | 44.0 42.9–45.2ROR 45.7 · calibrated p 2e-5 ✓ | 31.2 EB05 30.6 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 · 98% consumer | NCT00401752: 2/107 (1.9%) on Ranitidine (serious AE) |
| Pancreatic carcinoma | 6,840 | 32.5 31.6–33.4ROR 33.6 · calibrated p 1e-4 ✓ | 25.0 EB05 24.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · 99% consumer | not reported in cached trials |
| Lung neoplasm malignant | 6,760 | 20.6 20.1–21.1ROR 21.3 · calibrated p 0.001 ✓ | 17.4 EB05 17.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · 97% consumer | not reported in cached trials |
| Nausea | 4,748 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.096 | 0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 0.9 · serious PRR 0.6 · ♀ 76% (drug 52%) | NCT00838526: 4/59 (6.8%) on Ranitidine |
| Chronic kidney disease | 4,687 | 6.8 6.7–7.1ROR 7.0 · calibrated p 0.099 | 6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 7.8 · serious PRR 4.1 | not reported in cached trials |
| Fatigue (tiredness) | 4,494 | 0.6 0.6–0.6ROR 0.6 · calibrated p 0.086 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Not in label — unassessed | age-adj. PRR 0.9 · serious PRR 0.6 · ♀ 73% (drug 52%) | NCT00838526: 1/173 (0.6%) on Ranitidine (serious AE) |
| Drug ineffective (drug did not work) | 4,096 | 0.3 0.3–0.3ROR 0.3 · calibrated p 0.009 ✓ | 0.3 EB05 0.3 · IC025 -1.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.6 · serious PRR 0.4 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haematopoietic neoplasm — n=69, PRR 61.1
- Colorectal cancer — n=17,674, PRR 61.0
- Renal cancer — n=16,278, PRR 53.9
- Hepatic cancer — n=7,592, PRR 48.1
- Small intestine carcinoma — n=701, PRR 47.7
- Bladder cancer — n=16,746, PRR 41.3
- Prostate cancer — n=22,252, PRR 39.8
- Appendix cancer — n=250, PRR 38.3
- Breast cancer — n=24,854, PRR 37.9
- Gastrointestinal carcinoma — n=2,362, PRR 36.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ranitidine (Zantac) ↔ Cancer (breast, prostate, bladder, colorectal, renal).
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ranitidine?
In FDA FAERS, the most frequently co-reported reaction terms for Ranitidine are breast cancer, prostate cancer, colorectal cancer, bladder cancer, renal cancer, oesophageal carcinoma. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ranitidine have an FDA boxed warning?
No. The FDA label retrieved for Ranitidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ranitidine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0fba6615-37c2-4ba6-b6e5-09599369a5bc, effective 20251205; matched on
openfda.generic_name.exact:"RANITIDINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3001055 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,200 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
RANITIDINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.